Clinical Lead III

11 Premier Research International LLC; Florida; On-site; USD 110,000 - 134,000; Full time

Job summary

Premier Research seeks a Clinical Lead III to join our Clinical Management team in the United States. You will guide biotech, medtech, and pharma partners from study startup through delivery, ensuring quality and timelines while supporting site activation and risk management.

The ideal candidate has a bachelor’s degree in a clinical or life science field and at least four years in clinical leadership with onsite monitoring and risk-based monitoring experience.

Qualifications

• Bachelor’s degree in clinical, biological, scientific, or health-related field.
• At least 4 years of experience as a Clinical Lead.
• Onsite monitoring experience and knowledge of Risk-Based Monitoring preferred.

Responsibilities

• Lead large clinical/SSU teams to deliver studies.
• Align KOM meeting with SSU strategy and study budget.
• Collaborate with PM and support functions to set up systems and reports.
• Identify sites, obtain regulatory approval, and activate within timelines.
• Plan patient recruitment and retention strategies.

Skills

Leadership

Onsite monitoring

Risk-Based Monitoring

Communication

Regulatory knowledge

Education

Bachelor's degree in clinical or life sciences

Job description

Premier Research is looking for a Clinical Lead III to join our Clinical Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

What you’ll be doing:

• Significantly contributes to the KOM meeting to ensure a strong and aligned SSU and clinical delivery strategy and the proposed study budget aligns with execution expectations of the customer.
• Effectively leads large clinical/SSU teams.
• Significantly contributes to the Risk Assessment meeting to identify any protocol execution risks or other Clinical/SSU operational risks.
• Contributes to cross functional strategy and problem solving by collaborating with PM and other support functions to ensure clinical systems are set up, UAT’d, maintained and supports project and reporting needs.
• Collaborates with SSU team (eg Regulatory Submissions Leads, Site Start Up Associates, Contracts Leads/Specialists and/or Site Activation Leads) to ensure sites are identified, selected, approved by authorities/ethics committees and activated within the specified timeline/budget.
• Plans/oversees patient recruitment and retention strategies.
• Partners with CRAs to drive individual site enrollment targets.

What we’re searching for:

• Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience 4 years of experience as a Clinical Lead.
• Prior onsite monitoring experience including experience with Risk-Based Monitoring is preferred.
• Strong knowledge on global processes and regulations
• Strong understanding of other functional processes including QA.
• Excellent communication, presentation and soft skills to manage teams and sites effectively.
• Strong leadership skills including organizational skills, ability to persuade and motivate team members and sites to achieve targets.

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $122,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.

Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies.

As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose.

Premier is a place where you can change lives, and feel rewarded and celebrated.

We aim high - we will not stop until we reach our goals.

And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.